CN111601573A

CN111601573A - Implantable anchoring devices and methods of use

Info

Publication number: CN111601573A
Application number: CN201880085452.0A
Authority: CN
Inventors: Z·卡尔冯
Original assignee: ALLIUM MEDICAL SOLUTIONS Ltd
Current assignee: Olivetix Medical Co.,Ltd.
Priority date: 2018-01-03
Filing date: 2018-12-16
Publication date: 2020-08-28
Anticipated expiration: 2038-12-16
Also published as: EP3735207A1; WO2019135212A1; US10368976B2; US20190201182A1; CN111601573B; EP3735207A4; US20200170775A1; CN113576724A; US11547547B2; US20190201181A1; US10631971B2

Abstract

An implantable device comprising a plurality of links and configured to be in one of two modes that are flexible in at least one plane or rigid in all planes. The implantable device is inserted into the body lumen in a flexible mode and transformed into a rigid mode like the numeral 8 and anchors the device in the body lumen.

Description

Implantable anchoring devices and methods of use

This application claims the benefit OF us provisional patent application 62/613,065 entitled "IMPLANTABLEAANCHORING DEVICE AND METHOD OF USE", filed 2018, 1, 3, by the inventor Kalfon, Ziv, which is incorporated herein by reference.

Technical Field

The present disclosure generally relates to devices that are inserted into a body cavity using intraoral procedures and positioned within the body cavity by deformation of the device shape and stiffness.

Background

Several medical procedures require the placement of medical devices in the lumen of the human or animal body, and in particular the stomach. Once inserted, movement of the inserted medical device must be constrained, and this is achieved through the use of anchors. Us patent No. 9,636,245 describes a gastrointestinal device that includes a proximal element configured to reside in the stomach and a distal element configured to reside in the intestine, wherein the proximal element is configured to resist migration over time. U.S. patent application No. 2008/0058840 describes an alternative proximal element for placement within a hollow body organ. The proximal element comprises a member having a first shape for delivery to the hollow body and a second shape for implantation in the hollow body. The member has sufficient rigidity in its second shape to exert an outward force on the interior of the hollow body to bring together the two generally opposed faces of the hollow body. The examples of implants described in US 9,636,245 and US 2008/0058840 are subject to migration within the body's lumen and do not provide the long term required stability of the implant.

Disclosure of Invention

The present disclosure describes an implantable device comprising a plurality of links and configured to be in either of two modes: a flexible mode in at least one plane of the device, or a rigid mode in all other planes of the device. Implantable devices include at least, but are not limited to: a device closing pin; a locking unit; a quick release unit; a plurality of links, wherein each link is connected to two other links, or each link is connected to a link on one side and to a locking unit or a release unit on the opposite side. Implantable devices are inserted into a body cavity using intraoral procedures. During insertion, the device closure pin is attached at only one side, and in one example to the quick release unit, and the implantable device is in a soft mode in one plane. The flexibility of the implantable device provides the device with the ability to follow the contours of the body orifice and promotes insertion with minimal patient discomfort. The implantable device is releasably connected to the intraoral insertion apparatus at the locking unit. After the implantable device is inserted into the body and the device is installed in the target body cavity, the device closing pin is drawn into the locking unit and locked in place. The device closure pins are now attached at both sides and the implantable device is transformed into a rigid mode that provides an anchoring feature and prevents movement of the implantable device in the body lumen. In one example, a functional unit providing body related functions is attached to the release unit. An example of a functional unit is an intragastric sleeve adapted to reduce food intake in the intestine.

Drawings

Fig. 1A is an example of an implantable device comprising a plurality of links and configured to be flexible in at least one plane;

fig. 1B is an example of an implantable device including a plurality of links just prior to being configured to be rigid in all planes;

fig. 1C is an example of an implantable device that includes a plurality of links and is configured to be rigid in all planes;

fig. 2A is an example of a link of an implantable device;

fig. 2B is an example of a top view of a link portion of an implantable device;

fig. 2C is an example of a side view cross section of the link of the implantable device at tangent NN from fig. 2B;

FIG. 3A is an example of a device closing pin attached to a release unit;

FIG. 3B is an example of a side view of the device closing pin attached to the release unit;

FIG. 3C is an example of a rear view of the device closing pin attached to the release unit;

FIG. 4A is an example of a device closing pin attached to a receptacle;

FIG. 4B is an example of a side view of a device closure pin attached to a receptacle;

FIG. 4C is an example of a top view of a device closing pin attached to a receptacle;

fig. 5 is an example of a method of using an implantable device in a rigid state (151) to constrain movement of the device in a body lumen;

fig. 6A is an example of a wave anchor (503) in a folded configuration; and

fig. 6B is an example of a wave anchor in an extended configuration.

Detailed Description

In the following detailed description, reference is made to the accompanying drawings, which form a part hereof. In the drawings, like numerals generally refer to like parts unless the context indicates otherwise. The illustrative examples described in the detailed description, drawings, and claims are not intended to be limiting. Other examples may be employed and other changes may be made without departing from the spirit or scope of the subject matter presented herein. It will be readily understood that the aspects of the present disclosure, as generally described herein, and illustrated in the figures, can be arranged, substituted, combined, and designed in a wide variety of different configurations, all of which are explicitly contemplated and form part of this disclosure. In particular, the present disclosure relates to devices that are inserted into a human or animal body using intraoral procedures and positioned within a body cavity through deformation of the shape and rigidity of the device.

In the above described examples/patents of implantable devices, the proximal element is in contact with the pylorus. The proximal element is rounded in shape and thus it exerts an expansion force on the pylorus, which over time stretches the pyloric opening and displaces the proximal element. Such implants are subject to migration within the lumen or cavity of the human or animal body and do not provide the long term required stability of the implant. It is desirable to have a proximal element that is solid with a rounded shape in contact with the pylorus and provides the long-term required implant stability.

Fig. 1A is an example of an implantable device that includes a plurality of links and is configured to be flexible in at least one plane. Implantable devices include at least, but are not limited to: a lock unit (103); a quick release unit (105); a plurality of linking portions (101, 113, 115, 117, 119) (fig. 1B), wherein each linking portion (101, 113, 115, 117, 119) is connected to two other linking portions (101, 113, 115, 117, 119), or each linking portion is connected to a linking portion (101, 113, 115, 117, 119) on one side and to a locking unit (103) or a releasing unit (105) on the opposite side. Implantable devices are inserted into a body cavity using intraoral procedures. During insertion, the flexibility of the implantable device provides the device with the ability to follow the contours of the body orifice and promotes insertion with minimal patient discomfort. The implantable device is connected to a delivery or insertion apparatus at a locking unit (103). In one example, a functional unit providing body related functions is attached to the release unit (105). An example of a functional unit is an intragastric sleeve adapted to reduce food intake in the intestine.

Fig. 1B is an example of an implantable device including a plurality of links just before being configured to be rigid in all planes. By pulling the string (123) (fig. 1B) attached to the device closing pin (111) and passing through the locking unit (103), the implantable device transforms from the flexible mode depicted in fig. 1A to the rigid mode depicted in fig. 1C. The device closing pin (111) follows the string (123) into the locking unit (103), wherein the locking mechanism holds the device closing pin (111) in place. The locked device closure pin (111) applies a force to the links (101, 113, 115, 117, 119) of the implantable device, constraining relative movement of the links and transitioning the implantable device to a rigid mode. The transition of the implantable device from the rigid mode to the flexible mode facilitates removal of the implantable device from the body lumen. Removal of the release pin (111) from the locking unit (103) releases the device closure pin from the release unit (105) and transforms the implantable device into a flexible mode. After transforming the implantable device into the flexible mode, the implantable device is removed from the body cavity using intraoral surgery. Examples of materials for making the links (101, 113, 115, 117, 119) include, but are not limited to: titanium; stainless steel; cobalt, chromium, nickel titanium alloys, thermosets and similar materials or compositions of said materials. In a further example, use is made of

(polytetrafluoroethylene) or other damage-preventing material coats or covers the links. Examples of materials for the device closing pin (111) and the release pin (121) include, but are not limited to: stainless steel; titanium; cobalt, chromium, nickel titanium alloys, thermosets and similar materials or compositions of said materials. In one example, the links (101, 113, 115, 117, 119) of the implantable device are manufactured using an additive manufacturing process, such as 3D printing. The links (101, 113, 115, 117, 119), the locking unit (103), the quick release unit (105) and the interconnected pins are manufactured simultaneously and in a connected manner such that a connected closed profile of the links (101, 113, 115, 117, 119), the locking unit (103) and the quick release unit (105) is obtained at the time of an additive manufacturing cycle.

Thus, in one example, an implantable device is described, comprising: a plurality of linking sections (101, 113, 115, 117, 119); a device closing pin (111); a locking unit (103) attached and positioned between the two linking portions (117, 119); a release unit (105) attached and positioned between the two links (113, 115); wherein the plurality of linking portions (101, 113, 115, 117, 119), the locking unit (103) and the releasing unit (105) constitute a closed profile; and wherein the implantable device is in a flexible state when the device closure pin (111) is coupled to the locking unit (103) or the release unit (105), and in a rigid state when the device closure pin (111) is attached to both the locking unit (103) and the release unit (105).

Fig. 1C is an example of a side view of an implantable device in a rigid state (151) where a closed profile is formed and the device closure pin (111) forms the number 8. In an alternative example, an implantable device includes: a plurality of linking portions (101, 113, 115, 117, 119) constituting a closed loop, wherein one linking portion (101, 111, 113, 115, 117) is connected to two other linking portions (101, 113, 115, 117, 119); a device closing pin (111); wherein the implantable device is flexible when only one side of the device closure pin (111) is attached to the link (101, 113, 115, 117, 119), and rigid when both sides of the device closure pin (111) are attached to the link (101, 113, 115, 117, 119). In further examples, the closed profile of the implantable device in the rigid state (151) is elliptical and configured to follow a shape having two arcs (125, 127) and two interconnecting segments (131, 133), wherein the absolute radius of the interconnecting segments (125, 127) is at least 5 times the absolute radius of the arcs (125, 127). In further examples, the radius of the interconnecting segment (125, 127) is opposite in sign to the radius of the arcuate portion (125, 127). In further examples, the closed profile of the implantable device in the rigid state is elliptical and includes two arcs (125, 127) and two interconnected segments (131, 133), wherein the two interconnected segments (131, 133) are substantially straight. In further examples, the closed profile of the implantable device in the rigid state (151) has a figure 8 shape comprising two arcs (125, 127) and two connected interconnected segments (131, 133). The resulting shape of the implantable device in a rigid state in contact with the pylorus is generally flat and therefore does not exert a distraction force on the pylorus, ensuring long-term stability of the implanted device.

In further examples, the surfaces of all of the links (101, 113, 115, 117, 119) are atraumatic link surfaces made of titanium. In another example, the damage prevention property of the link (101, 113, 115, 117, 119) is passed

The coating or cladding is reinforced. In further examples, the links (101, 113, 115, 117, 119) are made using an additive manufacturing process.

In a further example, the release unit (105) comprises a removable pin (121) attaching the device closing pin (111) to the release unit (105), and removal of the removable pin (121) releases the device closing pin (111) from the release unit (105).

Fig. 2A is an example of a link (fig.

1A reference numerals

101, 113, 115, 117, 119) of an implantable device. The link (101) includes an attachment shaft (203) and a pin cavity (205). The attachment shaft (203) is configured to connect to the pin cavity (201) in the second link, thus creating a closed profile consisting of a plurality of links (101, 113, 115, 117, 119), wherein each link (101, 113, 115, 117, 119) is connected to two other links (101, 113, 115, 117, 119), or each link is connected on one side to a link (101) and on the opposite side to a locking unit (103, fig. 1B) or a release unit (105, fig. 1B). Fig. 2B is an example of a top view of a link (101) of an implantable device. Figure 2C is an example of a side view cross section of the link of the implantable device at tangent N-N from figure 2B. The link (101) includes an attachment shaft (203) and a pin cavity (201). The link also includes an angled side portion (205). In a flexible mode of the implantable device, one link (101) is connected to a second link (101), wherein the shaft (203) of the one link (101) is inserted in the pin cavity of the second link (101). The links (101) are free to move about the axles defined by their axes (203). Relative movement of the links (101) around the shaft provides a desired flexibility along one plane of the implantable device in a flexible mode. In the restrained mode, the inclined side (205) of one link (101) is pressed against the opposite side (211) of an adjacently connected link (101). The shape of the profile of the implantable device in the constrained mode is determined by the relative angle of the inclined side (205) of one link (101) and the opposite side (211) of the adjacent link (101) in contact with the inclined side (205). In further examples, the relative angles differ from link to configure the particular size shape of the closed profile of the implantable device in the rigid mode.

The support recess (207 or 209) comes into contact with the support recess (209 or 207) of the adjacent link at a preset maximum angle and provides a constraint for the relative movement of the link (101) in the flexible mode. In further examples, the link portion includes at least a base (220), one or more connection pins (203), and one or more vias (201). All links (fig. 1A, 101, 113, 115, 117, 119, and fig. 2A, 101) and pins (203) and pin holes (205) that make up the implantable device are manufactured simultaneously, such that the pin (203) of one link (101) is seated in the pin hole (205) of an adjacent link (101) or locking unit (fig. 1A, 103) or quick release unit (fig. 1A, 105), and provides a closed profile of the link (101), locking unit (fig. 1A, 103), and quick release unit (fig. 1A, 105) at the end of the additive manufacturing cycle.

In further examples, the link includes at least a base (220), one or more connecting shafts (203), and one or more apertures (201). In further examples, the base (220) of one link (101, 111, 113, 115, 117 in fig. 1B) and the connecting shaft (203) positioned in the pin hole (201) of a second link (101, 111, 113, 115, 117 in fig. 1B) are made simultaneously using an additive manufacturing process.

Fig. 3A is an example of the device closing pin (111) attached to the release unit (105). The top side of the device closing pin (111) is configured as a segment type engaging portion. The segmented engaging portion includes a recess (305) and a beveled tip (309).

In further examples, when the implantable device is in a flexible mode, a chord (fig. 1B, 123) is connected to the top of the beveled tip (309). The pulling string (fig. 1B, 123) will pull the device closing pin (111) into the receptacle, where the device closing pin is locked in place due to the recess (305). The device closure pin (111) also includes one or more quick release pin holes (307).

Fig. 3B is an example of a side view of the device closing pin attached to the release unit. The device closing unit (105) further comprises an attachment pin (315) and an attachment pin cavity (311) corresponding to the attachment pin (fig. 2C, 203) and the attachment pin cavity (fig. 2C, 201) of the link portion (fig. 2A, 101). The pins are used to attach the links on either side of the device closure unit. The device closing unit (105) further comprises a quick release housing (301) and a second pin hole (303). The device attachment pin is inserted into the quick release housing (301) and is held in place by inserting the quick release pin (121, fig. 1B) through the second pin hole (303) and the quick release pin hole (307) in the device closure pin (111). Prior to insertion in the body, the device closure pin (111) is attached to the quick release unit (105). The effective length of the device closing pin (111) is adjusted by the selection of which quick release pin hole (307) the quick release pin (121, fig. 1B) will pass through and lock the device pin (111) in place. The effective length of the device closure pin (111) determines the profile shape of the implantable device when in the rigid mode. In a further example, the profile shape is configured to be substantially flat for at least 1 link on either side of the quick release unit (105). The sleeve connection pin (321) is an anchoring point for connecting the implantable device to the chord of the intestinal sleeve. Fig. 3C is an example of a rear view of the device closing pin attached to the release unit.

Fig. 4A is an example of device closing pin (111) attached to receptacle (401). Fig. 4B is an example of a side view of device closing pin (111) attached to receptacle (401), and fig. 4C is an example of a top view of device closing pin attached to receptacle (401). In one example, the receptacle (401) includes an outer ring (403), a plurality of spokes (403) that terminate short of the center of the receptacle (401) and enable the beveled tip (309) of the device closure pin (111) to pass through the receptacle (401) by extending into the recess (305) of the device closure pin and then lock the device closure pin (111) in place. Examples of materials for making the receptacle include, but are not limited to: stainless steel; titanium; cobalt; chromium, nickel titanium alloys, thermosets and similar materials or compositions of said materials.

In further examples, the device closure pin (111) includes a beveled tip (309) configured to be inserted and locked into a receptacle (401) having an outer ring (405) and one or more spokes (403), and in further examples, the receptacle (401) is configured as a slotted spring washer and configured to receive and retain a snap-in segment of the device closure pin (111).

Fig. 5 is a method of constraining movement in a body lumen using an implantable device in a rigid state (151). In one example, the implantable device in a rigid state (151) is secured in the stomach (511). An intestinal sleeve (505) is attached to the implantable device in a rigid state (151) with a sleeve string (501) and inserted into the intestine (513). In further examples, the intestinal sleeve (505) includes a wave anchor (503) that positions it (the intestinal sleeve) in place. Fig. 6A is an example of a wave anchor (503) in a folded configuration, and fig. 6B is an example of a wave anchor in an extended configuration.

A number of examples have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the process. Accordingly, other examples are within the scope of the following claims.

Claims

1. An implantable device comprising:

a plurality of linking sections (113, 115, 117, 119);

a device closing pin (111);

a locking unit (103) attached and positioned between the two linking portions; and

a quick release unit (105) attached and positioned between the two links;

wherein the plurality of links (113, 115, 117, 119), locking unit (103) and quick release unit (105) constitute a closed profile; and is

Wherein the locking unit (103) comprises a receptacle (401) configured as a slotted spring washer and configured to receive and hold a snap-in segment of a device closing pin (111).

2. The implantable device of claim 1, wherein the surfaces of all links are atraumatic surfaces comprised of titanium.

3. The implantable device of claim 2, wherein the atraumatic surface of the link further comprises a polytetrafluoroethylene coating or cladding.

4. The implantable device of claim 1, wherein the link (113, 115, 117, 119) is made using an additive manufacturing process.

5. The implantable device of claim 1, wherein the link (113, 115, 117, 119) comprises at least a base (220), an attachment shaft (203), and one or more pin holes.

6. The implantable device of claim 5, wherein the base (220) of one link positioned in the pin hole of the second link and the attachment shaft (203) are made simultaneously using an additive manufacturing process.

7. The implantable device of claim 1, wherein the device closure pin (111) comprises a beveled tip configured for insertion and locking into a receptacle (401) having an outer ring (405) and one or more spokes (403).

8. The implantable device of claim 1, wherein the implantable device is in a flexible state when the device closure pin (111) is coupled to the locking unit (103) or the quick release unit (105), and the implantable device is in a rigid state when the device closure pin (111) is attached to both the locking unit (103) and the quick release unit (105).

(original) the implantable device of claim 1, wherein the quick release unit (105) comprises an extractable pin (121) attaching the device closure pin (111) to the release unit (105), and removal of the extractable pin (121) releases the device closure pin (111) from the release unit (105).

10. The implantable device of claim 1, wherein the closed profile of the implantable device in the rigid state (151) is elliptical and comprises two arcs (125, 127) and two interconnecting segments (131, 133), wherein the radius of the interconnecting segments (131, 133) is at least five times the radius of the arcs (125, 127).

11. The implantable device of claim 1, wherein the closed profile of the implantable device in the rigid state is elliptical and comprises two arcs (125, 127) and two interconnected segments (131, 133), wherein the two interconnected segments (131, 133) are substantially straight.

12. The implantable device according to claim 1, wherein the closed contour of the implantable device in the rigid state (151) is the number 8 comprising two arcs (125, 127) and two connected interconnecting segments (131, 133).

13. An implantable device comprising:

a plurality of links (113, 115, 117, 119) constituting a closed loop, wherein each link (113, 115, 117, 119) is connected to two other links; and

a device closing pin (111);

wherein the implantable device is flexible when only one side of the device closure pin (111) is attached to the link, and rigid when both sides of the device closure pin (111) are attached to the link; and is

Wherein at least one link comprises a receptacle (401), said receptacle (401) having a slotted spring washer, the receptacle being configured to receive and hold a snap-in segment of the device closing pin (111).

14. The implantable device of claim 13, wherein the surfaces of all links are atraumatic surfaces comprised of titanium, and wherein the atraumatic properties of the links further comprise a polytetrafluoroethylene coating or cladding.

15. The implantable device according to claim 13, wherein the link (113, 115, 117, 119) is made using an additive manufacturing process.

16. The implantable device of claim 13, wherein the link comprises at least a base (220), one or more connecting pins, and one or more pin holes.

17. The implantable device of claim 16, wherein the base (220) and one or more connecting pins located in pin holes of the second member are made using an additive manufacturing process.

18. The implantable device according to claim 13, wherein the device closure pin (111) comprises a snap-in section configured for insertion and locking into a receptacle having one or more holes.

19. The implantable device according to claim 13, wherein at least one link comprises a device closing pin (111) attached to a quick-extraction pin (121) of said at least one link, and removal of said quick-extraction pin (121) releases the device closing pin (111) from said at least one link.

20. A method of using an implantable device, comprising:

providing an implantable device comprising a plurality of links (113, 115, 117, 119), a device closure pin (111), a locking unit (103) attached and positioned between two links, and a quick release unit (105) attached and positioned between two links;

configuring the plurality of links (113, 115, 117, 119), the locking unit (103) and the release unit (105) into a closed profile, and wherein the closed profile of the implantable device in the rigid state (151) is the number 8 comprising two arcs (125, 127) and two connected interconnecting segments (131, 133).

21. The method according to claim 20, wherein a device closing pin (111) is attached to both the locking unit (103) and the release unit (105) and holds the implantable device in a rigid state.